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Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula

Primary Purpose

Anal Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Drainage seton with flap
EAS sparing seton
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suffering from high trans-sphincteric anal fistula

Exclusion Criteria:

  • Acute sepsis.
  • Specific cause of fistula e.g. Crohn's disease
  • Strictured anorectum.
  • Any degree of incontinence
  • Recurrent anal fistula.
  • Low anal fistula.
  • Previous anorectal surgery.

Sites / Locations

  • Mansoura university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Drainage seton with flap

EAS sparing seton

Arm Description

Drainage seton will be put around the external anal sphincter with mucosal advancement flap

Rerouting of the seton around the internal anal sphincter sparing the external sphincter will be done

Outcomes

Primary Outcome Measures

fecal incontinence
Number of patients who develop fecal incontinence as assessed by Wexner Incontinence score

Secondary Outcome Measures

Full Information

First Posted
June 10, 2019
Last Updated
June 15, 2019
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03983174
Brief Title
Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula
Official Title
Drainage Seton Around the External Anal Sphincter With Mucosal Advancement Flap Versus External Anal Sphincter Preserving Seton in Treatment of Trans-sphincteric Anal Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with high trans-sphincteric anal fistula will be randomized to one of two equal group: group 1 will have drainage seton with mucosal advancement flap and group 2 will undergo external anal sphincter sparing seton

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drainage seton with flap
Arm Type
Experimental
Arm Description
Drainage seton will be put around the external anal sphincter with mucosal advancement flap
Arm Title
EAS sparing seton
Arm Type
Experimental
Arm Description
Rerouting of the seton around the internal anal sphincter sparing the external sphincter will be done
Intervention Type
Procedure
Intervention Name(s)
Drainage seton with flap
Intervention Description
Seton is placed around the external sphincter then mucosal advancement flap will be constructed
Intervention Type
Procedure
Intervention Name(s)
EAS sparing seton
Intervention Description
Rerouting of the seton around the internal sphincter only sparing the external sphincter
Primary Outcome Measure Information:
Title
fecal incontinence
Description
Number of patients who develop fecal incontinence as assessed by Wexner Incontinence score
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from high trans-sphincteric anal fistula Exclusion Criteria: Acute sepsis. Specific cause of fistula e.g. Crohn's disease Strictured anorectum. Any degree of incontinence Recurrent anal fistula. Low anal fistula. Previous anorectal surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Emile, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula

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